Trial RPCEC00000317
Publication ATENEA-Co-300 - Cruz LR, ACS Pharmacol. Trans (2020) (published paper)
Dates: 2020-06-01 to 2020-06-16
Funding: Mixed (British Embassy in Cuba (FCDO); Center for Genetic Engineering and Biotechnology (CIGB); Ministry of Public Health.)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Cuba
Follow-up duration (days): 14
Inclusion criteria
  • Registry: Males and females confirmed as SARS-CoV-2 positive by RT-PCR:
    1) Patients who meet the diagnostic criteria for COVID 19 in categories 1 through 4 of the NIH guidelines.
    2) Age over 18 years.
    3) Voluntariness of the patient by signing the informed consent.
Exclusion criteria
  • Registry:
    1) Pregnancy or lactation at the time of inclusion in the study.
    2) Patients included in another clinical trial.
    3) Diseases that compromise the patient's state of consciousness or their possibility of giving their informed consent or collaborating in the trial.
    4) Critical illness, category 5 of the NIH Guidelines.
Interventions
Treatment
CIGB-325
2.5 mg/kg IV once a day for 5 days
Control
Standard care

Participants
Randomized
participants :
CIGB-325=10
Standard care=10
Characteristics of participants
N= 20
Mean age : NR
14 males
Severity : Mild: n=9 / Moderate: n=9 / Severe: n=2 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Reduction of the time to the negativization of the coronavirus detection test (time to the negative of the coronavirus detection test by PCR-RT in the nasopharynx). Measurement time: 48 hours and on the 7th day after starting the treatment.
In the report
NR
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the pre-print, the trial registry was also used in data extraction and risk of bias assessment. Some outcomes were not reported in the paper that were pre-specified in the registry. There was a change from the trial registration in the intervention treatment.
"CIGB-300 code used for cancer treatment was substituted by CIGB-325 just after the online registration of this clinical trial; therefore, it appears labeled with the former code."
The study achieved the target sample size specified in the registry.